FDAFDA · Food and drugs·Recall number D-0826-2018
Diclofenac Sodium and Misoprostol Delayed Release Tablets 75 mg/0.2 mg, 60-count bottle, Rx Only, Manufactured by: Cipla Ltd., India; For: EAGLE PHARMACEUTICALS, INC., Woodcliff Lake, NJ 07677 USA, NDC 42367-111-06.
Published May 30, 2018 · Recall initiated: April 20, 2018
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Labeling: Label Mix-Up: bottle labeled as Diclofenac Sodium and Misoprostol 75 mg/0.2 mg contained Diclofenac Sodium and Misoprostol 50 mg/0.2 mg tablets.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Exela Pharma Sciences LLC
- Distributor
- Nationwide in the USA and Puerto Rico
- Lot
- Lot: GH70154, Exp 12/18
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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